and regulatory standards.

4. Accountability

The QC Manager is accountable for ensuring that particle size analysis is performed in accordance with this SOP. The Production Supervisor is responsible for providing the representative samples for testing. The QA Manager ensures that the test results are reviewed and approved in compliance with GMP and regulatory standards.

5. Procedure

5.1 Pre-Test Preparation

1. Ensure that the necessary equipment for particle size analysis is available, including a laser diffraction analyzer, particle size analyzer, or any other suitable instruments for measurement.
2. Calibrate the particle size analyzer according to the manufacturer’s instructions to ensure accurate measurements.
3. Review the batch record to confirm the formulation details, including the type of emulsifier and stabilizer used, and the intended particle size distribution for the cream emulsion.

5.2 Sample Collection

1. Collect a representative sample of the cream emulsion from the finished batch. The sample should be homogenous and free from contamination.
2. Label the sample with the batch number, sample ID, sampling date, and other relevant details to ensure traceability during testing.
3. Ensure that the sample is collected from sealed containers to maintain the integrity of the emulsion and prevent contamination during testing.

5.3 Particle Size Analysis Procedure

1. Place the sample into the particle size analyzer. If necessary, dilute the sample with an appropriate solvent to achieve optimal concentration for analysis.
2. Set the analyzer to the appropriate particle size measurement mode (e.g., laser diffraction, dynamic light scattering) and initiate the measurement procedure.
3. Conduct at least three measurements for each sample to ensure consistency. The measurements should be performed at different time intervals if required (e.g., initial, after emulsification, and after storage).
4. Record the particle size distribution, including the mean particle size, median size, and span (a measure of the width of the size distribution) in the Particle Size Analysis Log (Annexure-1).

5.4 Interpretation of Results

1. Review the particle size distribution results, ensuring that the particle size is within the specified range for the cream formulation. Typically, emulsions with smaller particle sizes (less than 10 microns) are preferred for smooth texture and stability.
2. Acceptable particle size distribution is defined by the specification for the specific formulation. If the particle size is outside the acceptable range, mark the result as “Fail.”
3. If the test fails, investigate potential causes such as improper emulsification, insufficient mixing, or incorrect formulation components, and perform corrective actions as necessary.
4. Record all deviations, investigations, and corrective actions in the Particle Size Analysis Log (Annexure-1) and submit the results for further review.

5.5 Post-Test Activities

1. Record all test results, including batch number, sample ID, particle size distribution, and any corrective actions taken, in the Particle Size Analysis Log (Annexure-1).
2. If the particle size is found to be out of specification, initiate corrective actions such as reprocessing the emulsion or modifying the formulation, and re-test after corrective actions.
3. Submit the test results for review and approval by the QA team to ensure compliance with internal and regulatory standards.

5.6 Documentation and Record-Keeping

1. Ensure that all particle size analysis records are complete, accurate, and securely stored. This includes the Particle Size Analysis Log (Annexure-1) and the Deviation Log (Annexure-2) for failed tests.
2. Retain all records for a minimum of two years or as required by regulatory guidelines.
3. Ensure that records are reviewed and approved by the Quality Assurance team to verify compliance with GMP standards and regulatory requirements.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• μm: Micrometer (used for particle size)

7. Documents

1. Annexure-1: Particle Size Analysis Log
2. Annexure-2: Deviation Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• ISO 13320 – Particle Size Analysis – Laser Diffraction Methods
• International Pharmaceutical Excipients Council (IPEC) Guidelines on Emulsion Formulations

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Particle Size Analysis Log

Batch Number	Sample ID	Test Date	Particle Size (μm)	Operator
12345	S-001	21/01/2026	5.2	John Doe

Annexure-2: Deviation Log

Deviation Date	Batch Number	Deviation Description	Corrective Action Taken	Operator
21/01/2026	12345	Particle size out of specification	Reformulated and re-tested	Jane Smith

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head